The invention relates to a system for injecting water or other fluid into a human body cavity, such as an ear, for cleaning thereof More specifically, the invention is directed to a body cavity irrigation system which allows user/patient monitoring to ensure efficacy of a cleaning procedure and that water of an optimal temperature is delivered continuously to a body cavity of interest. Further, the system conveniently collects discharged water from the body cavity.
Irrigation syringes are known for cleaning human body cavities. For example, such devices can be used for routinely cleaning the ears of a patient. Most commonly, a flexible bulb is fitted to a nozzle through which fluid (water) is discharged into the ear canal of a patient.
Bulb-type devices have several drawbacks. First, the bulb capacity limits the usage of the device since the bulb contains a relatively small quantity of water. Often, and to fully irrigate a patient""s ear, the bulb may have to be refilled a number of times.
Second, the pressure of the water exiting the nozzle and impinging upon the ear canal can not be readily controlled in a reliable manner. This lack of control produces variable results and can in turn, cause pain and injure a patient due to the sensitivity of the tympanic membrane.
Other known irrigation devices incorporate mechanical pumps which interconnect a fluid reservoir with the nozzle. These devices are capable of producing pulsating streams of ejecting water from the nozzle opening for a sustained period of time. Besides being rather bulky and cumbersome, the above devices produce both vibration and noise which are associated with mechanical pumps. Each result is annoying and undesirable in a doctor""s office or similar setting. A further consideration with these devices is that the volume of the fluid reservoir, though greater than that of the flexible bulb-type devices, must also be refilled at periodic intervals.
In more recent advances, an irrigation-based ear wash device as described by U.S. Pat. No. 5,685,851, to Murphy et al, the entire contents of which are herein incorporated, includes a pressure regulator unit (a housing) having an inlet port which is fluidly connected to a faucet and a discharge port which is connected to an irrigation syringe. The irrigation syringe is hand-grippable and includes a push button control which selectively restricts the flow of liquid from the pressure regulator unit. The pressure regulator unit of this device permits connection to a continuous water source and includes a number of features, including a flow limiting orifice in a supply chamber, a defined air buffer, and a check valve, which effectively controls the pressure of water supplied by the faucet to produce a smooth and constant flow to the irrigation syringe.
At least two problems exist using any of the above described irrigation systems. A first probe relates to collection of the waste water after it has been discharged by the syringe. In the majority of prior art devices, such as described in U.S. Pat. No. 989,839, a basin is used to collect the waste water. If the basin is not used, then the patient must be irrigated in the vicinity of a sink in order to avoid spillages and further usually require the use of towels, drapes, and other accessories to attend to the discharged water. Using either method, the collection of waste water from a cleaning procedure is both tedious and time consuming, as well as inefficient.
A second problem long encountered in the field pertains to the temperature of water being discharged into the body cavity, especially in those systems that utilize a continuous water supply. Water which is too hot can create discomfort and in other cases could seriously injure the patient. It has further been determined that water which is too cold will not allow optimal cerumen removal. It has been determined that optimal removal is achieved using water which is at approximately body temperature.
Moreover, there appears to be no known irrigation system to date which can effectively and continuously deliver a fluid to a body cavity under controlled or regulated high pressure which further effectively solves each of the long standing problems that are noted above.
It is a primary object of the present invention to alleviate the above noted problems as encountered by prior art devices.
It is a further object of the present invention to provide a body cavity irrigation system having temperature controls which more reliably assures that water dispensed into a body cavity, such as the ear, permits cleaning at a comfortable near optimal temperature.
It is a further object of the present invention to provide an ear wash or other body cavity irrigation system that is capable of both delivering water continuously under pressure and removing discharged water away from the cavity without requiring cumbersome mechanical pumps or similar apparatus and precluding the use of drapes, basins, towels, and the like.
It is yet another primary object of the present invention to provide feedback to a user and/or patient such that either can effectively monitor the progress of a cleaning procedure.
It is yet a further object of the present invention to provide an ear wash or other body cavity irrigation system which is easy to use and operate repeatably.
It is yet a further object of the present invention to provide an irrigation system which is relatively inexpensive in terms of manufacture and which is simple and efficient in operation.
Therefore, and according to a preferred aspect of the invention, there is provided an irrigation system for cleaning a body cavity of a patient, said system comprising:
a housing fluidly connected to a liquid source through an inlet port, said housing further having at least one interior chamber and a discharge port;
a handpiece connected to the discharge port of said housing, said handpiece having an actuable control element to control the dispensing of liquid from said liquid source into a body cavity of the patient through a discharge opening; and
means for delivering liquid to the discharge opening of said handpiece which is of a suitable temperature for effectively cleaning the body cavity without discomfort.
According to the present invention, the delivering means includes means for assuring that liquid exceeding a first predetermined temperature is not dispensed from the housing. In a preferred embodiment, an anti-scald valve is provided including a metallic disc-like element formed from a temperature reactive material.
If the temperature of water impinging upon the disc-like element exceeds the first predetermined temperature, the disc-like element is caused to move from a first position to a second position to effectively block the flow of liquid from the housing to the handpiece and eliminate the possibility of dispensing water that is too hot and could cause injury to the patient.
In addition, at least one indicator is also provided to indicate when liquid which has been discharged from the housing exceeds a second predetermined temperature to indicate an appropriate temperature range for effective cleaning, e.g., cerumen removal. Preferably, the indicator(s) is composed of or at least partially coated with a thermally reactive material which changes color when water exceeds a second predetermined temperature. The indicator can be provided at the insertion tip or anywhere along the fluid delivery path.
An advantageous feature of the above described irrigation system, as described, is that liquid which is too hot and can cause injury is prevented from being discharged from the housing by an anti-scald valve. Furthermore and in the event the water passing through the discharge port of the housing is too cold, the indicator adjacent the handpiece indicates when the liquid has exceeded a second predetermined temperature, indicating that the temperature of the liquid is less than the first predetermined temperature and is at a temperature which is most effective for use and comfortable for the patient. In this manner, the user can monitor when the syringe contains liquid to be dispensed which has the optimum temperature.
According to another preferred aspect of the present invention, there is provided a system for cleaning a body cavity of a patient, said system comprising:
a housing fluidly connected to a liquid supply through an inlet port, said housing further including a plurality of interior chambers and a discharge port;
a handpiece fluidly interconnected to the discharge port of said housing, said handpiece having an actuable control element to control the dispensing of liquid from said liquid supply into the ear of the patient through a discharge opening;
an insertion tip having at least one tip opening attached to said handpiece and aligned with said discharge opening, said insertion tip sized to be fitted a predetermined distance into the ear of a patient; and
means for circulating liquid discharged into the ear of the patient through said insertion tip along a return path extending between said tip and said housing.
Preferably, the insertion tip includes a pair of cavities including a first cavity through which liquid is discharged into the ear from the discharge port of the housing and a second cavity through which liquid is recirculated to the housing along a return path. A pair of fluid channels are defined within the interior of the handpiece; a first channel in fluid communication between the discharge port of the housing and the first cavity of the insertion tip and a second channel in fluid communication between a return chamber of the housing and the second cavity of the insertion tip.
The liquid circulation means includes a return chamber provided in said housing and venturi means for drawing liquid discharged into the ear through the second cavity of the insertion tip and along a return path.
The venturi means includes a converging-diverging nozzle disposed in the return chamber, the return chamber further including a suction port fluidly interconnected with the handpiece along the return path.
Preferably, the insertion tip is disposable and can be made from a transparent material. The insertion tip can also be composed of or be coated with a thermally reactive material which changes color depending on the temperature of water in the tip.
An advantage of the present irrigation system is that the user can safely determine when to optimally dispense water for cleaning the ear or other body cavity.
A further advantage of the present system is that discharged liquid can be reliably and continually circulated to a sink or basin without the need for mechanical or electrical pumps or the need to refill the fluid source.
A further advantage of the present system is that it is more convenient to use than prior known devices since discharged water can be collected without the need of drapes, towels, or the like or otherwise requiring the patient to use a basin.
Yet another advantage of the present system is that a cleaning procedure performed using the system is simpler and more time efficient. Furthermore, the system provides lower patient risks in terms of both pressure and temperature while permitting continuous dispensing of water throughout a procedure.
Still another advantage provided by the herein described system is that the user or patient can monitor the efficacy of the cleaning procedure, for example, by examining a cerumen-catching filter of the insertion tip.
These and other objects, features, and advantages will be more apparent from the following Detailed Description which should be read in conjunction with the accompanying drawings.